ATMP Manufacturing Processes: Using Computer Simulation to Improve Operational Efficiency

Life Sciences, Pharma Manufacturing & Supply Chain, Cell and Gene Therapy,
  • Wednesday, April 12, 2023

Computer simulation empowers life sciences companies involved in manufacturing of advanced therapy medicinal products (ATMPs) to understand their systems and processes, compare scenarios and alternatives, and justify the cost of manufacturing and manufacturing-related processes.

More importantly, it can spur significant reductions in operating costs, capital costs, implementation time, and risk.

But what does computer simulation mean exactly in the context of ATMP manufacturing?

Simulation tools are computerized algorithms that use statistical modeling to predict the requirements for new manufacturing facilities. These tools estimate parameters such as equipment utilization; consumption of water, media, and buffer; and sampling frequency. The output of the simulation can be used to determine the size of ATMP manufacturing rooms, storage areas, and laboratories, as well as staffing and resource requirements, warehouse capacity, and the effects of variability.

This webinar will highlight the advantages of simulation and how the inputs used in the models can affect the results obtained. The quality of inputs is crucial. A poor input will result in poor output. But when the available data is used strategically, it can result in cost savings and operational efficiencies in ATMP manufacturing.

These benefits include:

  • Uncovering relationships between manufacturing steps that may affect throughput or efficiency
  • Predicting equipment utilization
  • Calculating the consumption of single-use components and estimating the quantity of in-process drums and containers
  • Encouraging the operations team to clearly define boundaries, such as staffing hours and product hold times

The featured speaker will highlight case studies from common ATMP manufacturing processes, such as CAR-T and viral vector, to demonstrate the principles discussed. These examples will highlight the value of using an analytic simulation tool, which is programmed using Microsoft Excel for these scenarios.

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These are batch processes that can take more than a week to complete. The duration of certain steps may vary depending on many factors, such as starting cell density, cell viability, and the consistency of the growth media. To avoid unnecessary staffing during weekends or late hours, some manufacturers may schedule specific times to start a batch or have provisions for holding intermediate products before continuing.

As multiple batches are run in a facility, conflicts over resources are inevitable. A simulation can identify these conflicts and pinpoint bottlenecks in equipment, rooms, and personnel. By leveling resources, the model can calculate the total number of batches that can be produced in the facility, determining the overall production capacity and equipment usage. Other resources, such as raw materials, may be identified by the model as necessary rather than limiting factors.

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Register for this webinar to learn how simulation tools can be used to streamline ATMP manufacturing.

Speaker

Steve Hall, Genesis AEC

Steve Hall, Chief Process Engineer, Genesis AEC

Stephen Hall has over 40 years of experience combining business understanding with technical expertise to deliver capital projects and services with exceptional value, speed, and compliance. Steve is recognized internationally as an expert on process engineering for upstream manufacturing facilities including small and large molecule APIs, critical utilities, CIP systems and material transfer. His book, Rules of Thumb for Chemical Engineers, 6th Edition, is a highly regarded handbook for process and project engineers. His engineering software is used globally for sizing pipelines and designing heat transfer systems.

Message Presenter

Who Should Attend?

This webinar will benefit senior professionals involved in ATMP manufacturing, including:

  • Project Engineers
  • Lab Managers
  • Head of Manufacturing
  • Process Engineers
  • Project Stakeholders
  • Maintenance Engineers
  • Facility Engineers

What You Will Learn

This webinar will highlight the advantages of simulation for ATMP manufacturing processes, including:

  • Uncovering relationships between manufacturing steps that may affect throughput or efficiency
  • Predicting equipment utilization
  • Calculating the consumption of single-use components
  • Encouraging the operations team to clearly define boundaries

Xtalks Partner

Genesis AEC

Since their inception, Genesis AEC, an award-winning architecture, engineering, and construction firm, has helped life sciences companies usher in the next generation of life-saving therapies, treatments, and technologies. Whether it’s providing AE support for existing sites; commissioning, validation, and qualification for specific processes or equipment; or turnkey design-build solutions, their team blends sound science and technical expertise with quality and safety to deliver unparalleled results.

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